Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 6:54 PM
Study NCT ID:
NCT03852758
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Green Exercise for Cancer - Creating Opportunities for Survivors
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Green Exercise for Cancer - Creating Opportunities for Survivors: Pilot Trial (GECCOS-PILOT)
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GECCOS
Brief Summary:
The purpose of this study is to assess feasibility and acceptability for a trial to evaluate exercise behaviors, fatigue and exercise motivation in adolescent and young adult survivors of childhood cancer who participate in an outdoor exercise intervention compared to survivors who participate in an indoor exercise intervention. A pilot randomized cross over design will allow participants to be compared to traditional controls as well as self-controls.
Detailed Description:
Title: Green Exercise for Cancer - Creating Opportunities for Survivors (GECCOS)
Rationale: Exercise is related to lower rates of late effects like fatigue, heart disease and second cancers among survivors of childhood cancer. Yet levels of exercise remain low among survivors. The context where exercise occurs - indoors or outdoors - may affect motivation to exercise and sustained exercise behavior. Yet the effects of exercise context on motivation and maintained behavior remain unexamined. This study aims to pilot test an outdoor exercise intervention for cancer survivors compared to attention controls receiving an indoor exercise intervention.
Target Population: Adolescent (13 to 17 years) and young adult (18 to 30 years) survivors of any cancer or hematopoietic cell transplantation for non-malignant disease.
Number of Participants :
16 to 20 participants (8 to 10 adolescents, 8 to 10 young adults).
Objective:
Pilot test, for feasibility and acceptability, a novel outdoor exercise intervention to motivate and maintain exercise in adolescent and young adult survivors of childhood cancer. Using a randomized cross-over design, participants will randomly receive both indoor and outdoor exercise sessions.
Study Design:
Randomized Cross-over Pilot Trial
Measures of Interest:
Primary Outcome - Accelerometer measured moderate to vigorous physical activity.
Secondary Outcomes - Self-Determination Theory based measures of motivation to exercise from validated survey questions. Fatigue, measured with validated survey questions.
Semi-structured qualitative exit interview will be used to assess acceptability and feasibility of the intervention.
Rationale: Exercise is related to lower rates of late effects like fatigue, heart disease and second cancers among survivors of childhood cancer. Yet levels of exercise remain low among survivors. The context where exercise occurs - indoors or outdoors - may affect motivation to exercise and sustained exercise behavior. Yet the effects of exercise context on motivation and maintained behavior remain unexamined. This study aims to pilot test an outdoor exercise intervention for cancer survivors compared to attention controls receiving an indoor exercise intervention.
Target Population: Adolescent (13 to 17 years) and young adult (18 to 30 years) survivors of any cancer or hematopoietic cell transplantation for non-malignant disease.
Number of Participants :
16 to 20 participants (8 to 10 adolescents, 8 to 10 young adults).
Objective:
Pilot test, for feasibility and acceptability, a novel outdoor exercise intervention to motivate and maintain exercise in adolescent and young adult survivors of childhood cancer. Using a randomized cross-over design, participants will randomly receive both indoor and outdoor exercise sessions.
Study Design:
Randomized Cross-over Pilot Trial
Measures of Interest:
Primary Outcome - Accelerometer measured moderate to vigorous physical activity.
Secondary Outcomes - Self-Determination Theory based measures of motivation to exercise from validated survey questions. Fatigue, measured with validated survey questions.
Semi-structured qualitative exit interview will be used to assess acceptability and feasibility of the intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: